MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HD SYS. W/O CDX BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	191128
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A fresenius field service technician (fst) reported that the blood pump rotor cover on the 2008t machine was cracked and tore through the fresenius combi set bloodlines during a patient¿s hemodialysis (hd) treatment, causing a blood leak to occur.Upon follow up with the user facility registered nurse (rn), it was confirmed that the event occurred during the patient¿s treatment and the machine did provide air detected alarms to alert the staff to the issue.The rn stated that the issue was discovered when it was visually observed by the medical staff.There was no defect or damage noted to the bloodlines prior to the occurrence of this issue.The rn stated that the bloodlines appeared to have been torn by the machine.The patient¿s estimated blood loss (ebl) was approximately 100 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient successfully completed treatment on a different machine with new supplies.The blood pump rotor was replaced to resolve the reported issue.The machine has been returned to service.The complaint device is available to be returned for physical evaluation by the manufacturer.
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.However, an on-site evaluation was performed by fresenius field service technician (fst).The blood pump rotor was replaced to resolve the reported issue.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was able to confirm the reported failure mode.During the machine inspection, the fst reported the blood pump rotor cover on the 2008t machine was cracked and tore through the fresenius combi set bloodlines during a patient¿s hemodialysis (hd) treatment, causing a blood leak to occur.Therefore, the complaint event was confirmed.
Event or Problem Description
A fresenius field service technician (fst) reported that the blood pump rotor cover on the 2008t machine was cracked and tore through the fresenius combi set bloodlines during a patient¿s hemodialysis (hd) treatment, causing a blood leak to occur.Upon follow up with the user facility registered nurse (rn), it was confirmed that the event occurred during the patient¿s treatment and the machine did provide air detected alarms to alert the staff to the issue.The rn stated that the issue was discovered when it was visually observed by the medical staff.There was no defect or damage noted to the bloodlines prior to the occurrence of this issue.The rn stated that the bloodlines appeared to have been torn by the machine.The patient¿s estimated blood loss (ebl) was approximately 100 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient successfully completed treatment on a different machine with new supplies.The blood pump rotor was replaced to resolve the reported issue.The machine has been returned to service.The complaint device is available to be returned for physical evaluation by the manufacturer.

• Brand Name: 2008T HD SYS. W/O CDX BLUE STAR
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 17541841
• Report Number: 0002937457-2023-01200
• Device Sequence Number: 20466705
• Product Code: KDI
• UDI-Device Identifier: 00840861102105
• UDI-Public: 00840861102105
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K173972
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 191128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 08/14/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS DIALYZER; FRESENIUS DIALYZER
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 75 KG